Urethral Dilator Endoscope
FDA 510(k) K874530 · Advanced Surgical Intervention, Inc.
510(k) numberK874530
Submission
- Device name
- Urethral Dilator Endoscope
- Applicant
- Advanced Surgical Intervention, Inc.
San Clemente, CA, US - Received
- November 3, 1987
- Decision date
- January 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOB – Catheter, Suprapubic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5090
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
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|---|---|---|---|
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage SetKOB · Traditional | Applied Medical Technology, Inc. | 11/01/2024SE |
| K181097 | Cook Cystostomy Catheter SetKOB · Traditional | Cook Incorporated | 01/18/2019SESK |
| K182709 | One-Step Suprapubic IntroducerKOB · Traditional | Cook Incorporated | 12/26/2018SE |
| K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetKOB · Traditional | Cook Incorporated | 10/30/2018SESK |
| K132890 | Suprapubic Catheter and Introducer SetKOB · Traditional | Mediplus , Ltd. | 01/17/2014SE |
| K120127 | Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemKOB · Traditional | Swan Valley Medical, Incorporated | 10/26/2012SE |
| K014002 | All Silicone Supra-Pubia Catheter, Models 4880/4890KOB · Traditional | Fortune Medical Instrument Corp. | 03/04/2002SE |
| K012153 | Lowsley Suprapubic TractorKOB · Traditional | Circon Video | 09/19/2001SE |
| K970969 | Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetKOB · Traditional | The Kendal Co. | 04/23/1997SE |
| K970021 | Rusch Suprapubic TrayKOB · Traditional | Rusch, Inc. | 02/07/1997SE |
More from Rusch, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954215 | MiniguardMNG · Traditional | 05/08/1996SE |
| K926110 | Asi Ligasure(Tm) Suture Ligation InstrumentGCJ · Traditional | 07/08/1993SE |
| K930361 | Asi Cystolase Laser CystoscopeGEX · Traditional | 04/29/1993SE |
| K921990 | Asi Uroplasty Laser CystoscopeGEX · Traditional | 10/28/1992SE |
| K902585 | Uroplasty Tcu Prostatic Urethroplasty CatheterKOE · Traditional | 08/27/1990SE |
| K901336 | Asi Hemostasis CatheterGBM · Traditional | 06/20/1990SE |
| K896713 | Asi Tcu Prostatic Urethroplasty Catheter & Access.KOE · Traditional | 05/24/1990SE |
| K895182 | Asi Cystoscope Sheath, Grasping Forceps & For.BodyFAJ · Traditional | 10/24/1989SE |
Questions and answers
When was Urethral Dilator Endoscope cleared by the FDA?
Urethral Dilator Endoscope (K874530) received a 510(k) decision of Substantially Equivalent on January 27, 1988, 85 days after the submission was received.
What is the product code of K874530?
The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.